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850523007327
EUDAMEDClass I (EU MDR)
Ref 850523007327Model Celluma Barrier Sleeve Large
Identity
- Model / Reference
- Celluma Barrier Sleeve Large EUDAMED850523007327 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850523007327 EUDAMED
- Basic UDI-DI
- B-00850523007327 EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Red-light phototherapy unit, professional
850523007327 by BioPhotas, Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850523007327 | Class I | Active |
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Manufacturer
- Manufacturer
- BioPhotas, Inc.
- EUDAMED SRN
- US-MF-000013481
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED ece24cf3-5790-4329-96a2-69d577ddd960 61 fields · synced Jul 26, 2026